Actively Recruiting
ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer
Led by Hansoh BioMedical R&D Company · Updated on 2025-02-13
560
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and efficacy of HS-20093 in combination with other anti-cancer agents in patients with advanced metastatic colorectal cancer.
CONDITIONS
Official Title
ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at screening
- Confirmed locally advanced or metastatic colorectal cancer by tissue diagnosis
- For dose escalation: patients progressed on or intolerant to standard therapies
- For dose expansion: patients not previously treated for advanced/metastatic colorectal cancer
- At least one measurable tumor lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Life expectancy of 12 weeks or more
- Men and women must use adequate contraception during the study
- Female participants must not be pregnant and have evidence of non-childbearing potential
- Signed and dated informed consent form
You will not qualify if you...
- Previous or current treatment with B7-H3 targeted therapy or ADCs with topoisomerase I inhibitors
- Cytotoxic chemotherapy, investigational drugs, or targeted therapy within 14 days before first HS-20093 dose
- Macromolecule anti-tumor therapy or other anticancer drugs within 28 days before first HS-20093 dose
- Radiotherapy for palliation within 2 weeks, or large field radiation within 4 weeks before first HS-20093 dose
- Pleural or peritoneal effusion needing clinical intervention or pericardial effusion
- Major surgery within 4 weeks before first HS-20093 dose
- Spinal cord compression or brain metastases
- Use of strong CYP3A4 inhibitors, inducers, or sensitive substrates within 7 days before first dose or during study
- Use of drugs that prolong QT interval or cause torsade de pointe during study
- Unresolved toxicities greater than Grade 2 except treated hypothyroidism, alopecia, or neurotoxicity
- History of other primary cancers
- Inadequate bone marrow or organ function
- Evidence or history of cardiovascular risk or severe uncontrolled cardiovascular disease
- Diabetes ketoacidosis or hyperglycemia within 6 months before first dose
- Severe or uncontrolled hypertension
- Significant bleeding or bleeding tendency within 1 month before first dose
- Serious thrombosis within 3 months before first dose
- Severe infections within 4 weeks before first dose
- Long-term steroid use or immunodeficiency conditions
- Active infections such as hepatitis B, C, tuberculosis, syphilis, or HIV
- Severe liver disease or cirrhosis of Child-Pugh Grade B or worse
- Moderate or severe lung diseases affecting treatment or detection
- Serious neurological or mental disorders interfering with assessment
- Women who are pregnant, breastfeeding, or planning pregnancy during study
- Vaccination or hypersensitivity reactions within 4 weeks before first dose
- History of severe hypersensitivity or allergy to study drug components
- Unlikely to comply with study procedures or safety concerns by investigator
- Any condition that could compromise safety or interfere with assessments according to investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Ying Yuan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
5
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